IDMC Recommends Continuation of Ph 3 REGAL Trial Without Any Modifications

“We are encouraged with another positive review and the IDMC’s recommendation to continue the Phase 3 REGAL trial in AML without any modifications,” said Angelos Stergiou, MD, ScD hc, President and Chief Executive Officer of SELLAS. “The committee’s review did not raise any safety or futility concerns, further strengthening our confidence in the potential of GPS as a safe and effective treatment option for AML patients. This is the first time the IDMC has provided guidance regarding the timing of the expected interim analysis, by the fourth quarter of this year, based on their thorough analysis of the REGAL trial data.”
Share:
More News
PharmaMar has submitted a Marketing Authorization Application to the European Medicines Agency for Zepzelca® (lurbinectedin) in combination with atezolizumab (Tecentriq®) for the maintenance treatment of adult patients with extensive-stage small cell lung cancer, whose disease has not progressed after first-line induction therapy with atezolizumab, carboplatin and etoposide. The MAA submission
“At SR One, our mission is to invest in companies that we believe have the ability to innovate and advance transformational new therapies in areas of high unmet medical need,” said Simeon George, M.D., Chief Executive Officer and Managing Partner at SR One. “Fore Bio is focused on resetting the
The study demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of TACE-progression-free survival (TACE PFS*), and the other primary endpoint of overall survival (OS) is immature at the prespecified first interim analysis. Meanwhile, a clinically meaningful PFS by RECIST v1.1** was also observed. Detailed findings from
“The positive CHMP recommendation for the Itovebi-based regimen represents a significant step towards providing people in the EU with PIK3CA-mutated, ER-positive advanced breast cancer with a targeted therapy in the first-line setting,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “This recommendation is